Study on UCART20x22 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Using a Drug Combination

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What is this study about?

This clinical trial is focused on studying a type of cancer called B-cell Non-Hodgkin Lymphoma, specifically in cases where the disease has returned or has not responded to previous treatments. The study is testing a new treatment called UCART20x22, which is a type of cell therapy. Cell therapy involves using specially engineered cells to target and fight cancer cells. In this case, the treatment targets specific proteins on the cancer cells known as CD20 and CD22.

The purpose of the study is to evaluate the safety and effectiveness of UCART20x22 in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma. The study is divided into two parts: the first part aims to find the best dose of the treatment, while the second part will further test the treatment’s safety and confirm the best dose. Participants will receive the treatment through an intravenous infusion, which means it will be administered directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and the treatment’s ability to control the cancer. The study will also involve other medications, such as Fludarabine and Cyclophosphamide, which are commonly used in cancer treatment. These medications help prepare the body to receive the cell therapy. The trial will continue for several years to gather comprehensive data on the treatment’s long-term effects and benefits.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking age, organ function, and previous test results for infections such as hepatitis B, hepatitis C, and HIV.

A pregnancy test is performed for women of childbearing potential. The performance status is evaluated to ensure it meets the required criteria.

2 pre-treatment preparation

Before starting the treatment, any previous treatment-related side effects must be resolved to a certain level. Autologous hematopoietic stem cells should be available if there is a high risk of prolonged blood-related side effects.

3 treatment phase

The treatment involves several medications administered intravenously. The medications include fludarabine phosphate, cyclophosphamide, and alemtuzumab. The specific dosages and frequency are determined based on the study’s requirements.

The main medication being studied is UCART20x22, which is also administered intravenously. The goal is to find the right dose and evaluate its safety and effectiveness.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the safety and any side effects of the treatment. This includes checking for any adverse events and the body’s response to the treatment.

The study aims to understand how the treatment affects the disease and the patient’s overall health. This involves regular follow-up visits and assessments.

5 end of study

At the end of the study, a final assessment is conducted to evaluate the overall impact of the treatment. This includes reviewing the patient’s health status and any changes in the disease.

The study’s findings contribute to understanding the treatment’s potential benefits and risks for future patients.

Who Can Join the Study?

Age between 18 and 80 years.
Must have adequate organ function, which means the kidneys, liver, heart, lungs, and bone marrow are working well.
Must test negative for hepatitis B using a blood test.
If considered high-risk for long-term blood-related side effects, must have their own stem cells available before starting treatment.
Must test negative for hepatitis C and HIV (human immunodeficiency virus).
Women who can have children must have a negative pregnancy test within 7 days before joining the study.
Must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
Must have relapsed or refractory mature B-cell Non-Hodgkin lymphoma that is positive for CD20 and/or CD22.
Must have a type of Non-Hodgkin lymphoma that fits the study criteria, excluding certain types like chronic lymphocytic leukemia and Burkitt’s lymphoma.
Must have had at least 2 previous treatments for their lymphoma, including specific types of drugs and therapies.
Must have at least one measurable tumor according to specific medical guidelines.
Any side effects from previous lymphoma treatments must have improved to their normal state or to a mild level before starting the study treatment.

Who Cannot Join the Study?

Patients with a history of another type of cancer, unless it has been in complete remission for at least 2 years.
Patients who have had a heart attack or stroke in the past 6 months.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with known allergies to the study medication or its ingredients.
Patients who have received another investigational drug within the last 4 weeks.
Patients with severe liver or kidney disease.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients with a history of severe allergic reactions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Saint Eloi	Montpellier	France
Aovvwobidc Pmeczrry Huaqlzgk Di Piwwr	Paris	France
Cgai Dm Nlstb	Vandoeuvre Les Nancy	France
Hotmjncp Vhoc dugeipla	Barcelona	Spain
Ihhbztcx Pjwsstrpbvkvyea Cubbej Cqmggs	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.01.2023
Italy	Not yet recruiting	01.01.2023
Spain	Recruiting	01.01.2023

Trial locations

Investigated drugs:

UCART20x22 is a type of therapy that uses specially modified cells to help fight cancer. In this trial, it is being tested on people with a type of cancer called B-cell Non-Hodgkin Lymphoma, which has come back or has not responded to other treatments. The therapy involves using cells that have been changed in a lab to better recognize and attack cancer cells in the body. The goal is to see if this treatment is safe and how well it works in shrinking or controlling the cancer.

Investigated diseases:

Relapsed or refractory B-cell Non-Hodgkin lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The disease is characterized by the return or persistence of cancer after initial treatment. It typically involves the uncontrolled growth of abnormal B-cells, which can form tumors in lymph nodes and other parts of the body. As the disease progresses, it can spread to other organs and tissues, disrupting normal bodily functions. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with periods of remission and relapse.

Trial ID:

2022-501607-27-00

NCT ID:

NCT05607420

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on UCART20x22 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Using a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?